thaw each vial before use - moderna, inc. | home...2 to 8 c (36 to 46 f) 8 to 25 c (46 to 77 f)...

2° to 8°C (36° to 46°F)

8° to 25°C (46° to 77°F)

Refrigerator

Cool storage up to room temperature

24 hours

30 days

Frozen Storage

Thaw Each Vial Before Use

–50° to –15°C (–58° to 5°F )Do not store on dry ice or below -50ºC (-58ºF).

Store in the original carton to protect from light.

Can be stored frozen until expiration date*

Thawed Shelf Life

NEVER refreeze thawed vaccine

Unpunctured Vial After First Dose Has Been Withdrawn

EMERGENCY USE AUTHORIZATION The Moderna COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID-19.The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.

AUTHORIZED USE Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Moderna COVID-19 Vaccine is investigational and not approved by FDA.

Maximum times

Refrigerator or room temperature

12 hours

Maximum time

Vial should be held between 2° to 25°C (36° to 77°F). Record the date

and time of first use on the vial label. Discard punctured vial after 12 hours.

1 of 3

2° to 8°C (36° to 46°F)

15° to 25°C (59° to 77°F)

Let vial sit at room temperature for 15 minutes before administering

Vial images for illustrative purposes only

OR

*Confirm vaccine expiration date by looking up the lot number at modernatx.com/covid19vaccine-eua

IMPORTANT SAFETY INFORMATIONContraindications Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.

Moderna COVID-19 Vaccine Storage & Handling

See Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information, Fact Sheet for Recipients and Caregivers, and EUA Letter of Authorization beginning on page 4 of this document.

Refrigerator Maximum 11-dose vial: 2 hours 30 minutes

Maximum 15-dose vial: 3 hours

Room temperature Maximum 11-dose vial: 1 hour

Maximum 15-dose vial: 1 hour 30 minutes

Confirm liquid is white to off-white in color in both vial and syringe

Provide a vaccination card to the recipient or their caregiver with the date the recipient needs to return for the SECOND DOSE of Moderna COVID-19 Vaccine.

The Moderna COVID-19 Vaccine is administered

intramuscularly as a series of two doses (0.5 mL each)

1 month apart.

Dosing and Schedule

Administration

Verify syringe volume of 0.5 mL If the amount of vaccine remaining in the vial cannot

provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials. Pierce the

stopper at a different site each time.

Prior to injection, inspect each dose to:

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of the Moderna COVID-19 Vaccine should receive a second dose of

the Moderna COVID-19 Vaccine to complete the vaccination series.

For any questions, contact Moderna Medical Information at: 1-866-MODERNA (1-866-663-3762)

The vaccine may contain white or translucent product-related particulates.

Do not administer the vaccine if it is discolored or contains other particulate matter.

IMPORTANT SAFETY INFORMATION (CONT.)Warnings and Precautions• Management of Acute Allergic Reactions: Appropriate medical

treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

• Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.

• Limitations of Vaccine Effectiveness: The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

2 of 3

Moderna COVID-19 Vaccine Dosing & Administration

Swirl vial gently after thawing and between each withdrawal. The vaccine comes ready to use once thawed. Do not shake or dilute.


IMPORTANT SAFETY INFORMATION (CONT.)

Adverse Reactions Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration ErrorsThe vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):

• vaccine administration errors whether or not associated with an adverse event• serious adverse events (irrespective of attribution to vaccination)• cases of Multisystem Inflammatory Syndrome (MIS) in adults• cases of COVID-19 that result in hospitalization or death

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. Reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.

Report to ModernaTX, Inc. by calling 1-866-MODERNA (1-866-663-3762) or provide a copy of the VAERS form by faxing 1-866-599-1342 or emailing [email protected].

Pregnancy and Lactation Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

Dosing and ScheduleThe Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.


Learn more about mRNA at ModernaTX.com

3 of 3 US-COV-2100123 04/2021© 2021 Moderna, Inc.

Revised: Mar/31/2021 1

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING

VACCINE (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF

THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019

(COVID-19)

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization

(EUA) to permit the emergency use of the unapproved product, MODERNA COVID-19

VACCINE, for active immunization to prevent COVID-19 in individuals 18 years of age and

older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all

vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory

Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death

following administration of the Moderna COVID-19 Vaccine. See “MANDATORY

REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER

EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Moderna COVID-19 Vaccine is a suspension for intramuscular injection administered as a

series of two doses (0.5 mL each) 1 month apart.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have

been updated. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccine-

eua.

For information on clinical trials that are testing the use of the Moderna COVID-19 Vaccine for

active immunization against COVID-19, please see www.clinicaltrials.gov.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus,

SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect

other organs. People with COVID-19 have reported a wide range of symptoms, ranging from

mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus.

Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle and body

aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or

vomiting; diarrhea.

DOSAGE AND ADMINISTRATION

Storage and Handling

The information in this Fact Sheet supersedes the information on the vial and carton labels.

During storage, minimize exposure to room light.


The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50º to -15ºC

(-58º to 5ºF). Store in the original carton to protect from light.

Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures

colder than -50°C (-58°F).

Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first

use.

Vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to

77°F). Vials should be discarded 12 hours after the first puncture.

Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

Transportation of Thawed Vials at 2° to 8°C (35° to 46°F)

If transport at -50° to -15°C (-58° to 5°F) is not feasible, available data support transportation of

one or more thawed vials for up to 12 hours at 2° to 8°C (35° to 46°F) when shipped using

shipping containers which have been qualified to maintain 2° to 8°C (35° to 46°F) and under

routine road and air transport conditions with shaking and vibration minimized. Once thawed and

transported at 2° to 8°C (35° to 46°F), vials should not be refrozen and should be stored at 2° to

8°C (35° to 46°F) until use.

Dosing and Schedule

The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5

mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with

other COVID-19 vaccines to complete the vaccination series. Individuals who have received one

dose of the Moderna COVID-19 Vaccine should receive a second dose of the Moderna COVID-

19 Vaccine to complete the vaccination series.

Dose Preparation

• The Moderna COVID-19 Vaccine multiple-dose vials contain a frozen suspension that

does not contain a preservative and must be thawed prior to administration.

• Remove the required number of vial(s) from storage and thaw each vial before use

following the instructions below.


Vial

Thaw in Refrigerator Thaw at Room Temperature

Maximum

11-Dose Vial

(range: 10-11

doses)

Thaw in refrigerated conditions

between 2° to 8°C for 2 hours

and 30 minutes. Let each vial

stand at room temperature for 15

minutes before administering.

Alternatively, thaw at room

temperature between 15° to

25°C for 1 hour.

Maximum

15-Dose Vial

(range: 13-15

doses)


between 2° to 8°C for 3 hours.

Let each vial stand at room

temperature for 15 minutes

before administering.



25°C for 1 hour and 30

minutes.

• After thawing, do not refreeze.

• Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not

dilute the vaccine.

• The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain

white or translucent product-related particulates. Visually inspect the Moderna COVID-

19 Vaccine vials for other particulate matter and/or discoloration prior to administration.

If either of these conditions exists, the vaccine should not be administered. • The Moderna COVID-19 Vaccine is supplied in two multiple-dose vial presentations:

o A multiple-dose vial containing a maximum of 11 doses: range 10-11 doses (0.5

mL each).


mL each).

• Depending on the syringes and needles used for each dose, there may not be sufficient

volume to extract more than 10 doses from the maximum of 11 doses vial or more than

13 doses from the maximum of 15 doses vial. Irrespective of the type of syringe and

needle:

o Each dose must contain 0.5 mL of vaccine.

o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5

mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.

o Pierce the stopper at a different site each time.

• After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36°

to 77°F). Record the date and time of first use on the Moderna COVID-19 Vaccine vial

label. Discard vial after 12 hours. Do not refreeze.

Administration

Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to

administration. The white to off-white suspension may contain white or translucent product-

related particulates. During the visual inspection,

• verify the final dosing volume of 0.5 mL.

• confirm there are no other particulates and that no discoloration is observed. • do not administer if vaccine is discolored or contains other particulate matter.


Administer the Moderna COVID-19 Vaccine intramuscularly.

CONTRAINDICATION

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of a

severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19

Vaccine (see Full EUA Prescribing Information).

WARNINGS

Appropriate medical treatment to manage immediate allergic reactions must be immediately

available in the event an acute anaphylactic reaction occurs following administration of the

Moderna COVID-19 Vaccine.

Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse

reactions according to the Centers for Disease Control and Prevention guidelines

(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may

have a diminished immune response to the Moderna COVID-19 Vaccine.

The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

ADVERSE REACTIONS

Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19

Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills,

nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema

at the injection site. (See Full EUA Prescribing Information)

Severe allergic reactions, including anaphylaxis, have been reported following administration of

the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more

widespread use of the Moderna COVID-19 Vaccine.

USE WITH OTHER VACCINES

There is no information on the co-administration of the Moderna COVID-19 Vaccine with other

vaccines.

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their caregiver,

information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy

or direct the individual to the website www.modernatx.com/covid19vaccine-eua to obtain the

Fact Sheet) prior to the individual receiving each dose of the Moderna COVID-19 Vaccine,

including:

• FDA has authorized the emergency use of the Moderna COVID-19 Vaccine, which is not

an FDA-approved vaccine.

• The recipient or their caregiver has the option to accept or refuse the Moderna COVID-19


Vaccine.

• The significant known and potential risks and benefits of the Moderna COVID-19

Vaccine, and the extent to which such risks and benefits are unknown.

• Information about available alternative vaccines and the risks and benefits of those

alternatives

For information on clinical trials that are evaluating the use of the Moderna COVID-19 Vaccine

to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the date when the recipient

needs to return for the second dose of Moderna COVID-19 Vaccine.

Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine

recipients to participate in v-safe. V-safe is a new voluntary smartphone-based tool that uses text

messaging and web surveys to check in with people who have been vaccinated to identify

potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor

the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live

telephone follow-up by CDC if participants report a significant health impact following COVID-

19 vaccination. For more information, visit: www.cdc.gov/vsafe.

MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE

ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION

In order to mitigate the risks of using this unapproved product under EUA and to optimize the

potential benefit of the Moderna COVID-19 Vaccine, the following items are required. Use of

unapproved Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 under

this EUA is limited to the following (all requirements must be met):

1. The Moderna COVID-19 Vaccine is authorized for use in individuals 18 years of age and

older.

2. The vaccination provider must communicate to the individual receiving the Moderna

COVID-19 Vaccine or their caregiver information consistent with the “Fact Sheet for

Recipients and Caregivers” prior to the individual receiving the Moderna COVID-19

Vaccine.

3. The vaccination provider must include vaccination information in the state/local

jurisdiction’s Immunization Information System (IIS) or other designated system.

4. The vaccination provider is responsible for mandatory reporting of the following to the

Vaccine Adverse Event Reporting System (VAERS):

• vaccine administration errors whether or not associated with an adverse event,

• serious adverse events* (irrespective of attribution to vaccination),

• cases of Multisystem Inflammatory Syndrome (MIS) in adults, and

• cases of COVID-19 that result in hospitalization or death.

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html.


For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should

include the words “Moderna COVID-19 Vaccine EUA” in the description section of the

report.

5. The vaccination provider is responsible for responding to FDA requests for information

about vaccine administration errors, adverse events, cases of MIS in adults, and cases of

COVID-19 that result in hospitalization or death following administration of the Moderna

COVID-19 Vaccine to recipients.

*Serious adverse events are defined as:

• Death;

• A life-threatening adverse event;

• Inpatient hospitalization or prolongation of existing hospitalization;

• A persistent or significant incapacity or substantial disruption of the ability to

conduct normal life functions;

• A congenital anomaly/birth defect;

• An important medical event that based on appropriate medical judgement may

jeopardize the individual and may require medical or surgical intervention to

prevent one of the outcomes listed above.

OTHER ADVERSE EVENT REPORTING TO VAERS AND MODERNATX, INC.

Vaccination providers may report to VAERS other adverse events that are not required to be

reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information

below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email Fax number Telephone number

[email protected] 1-866-599-1342 1-866-MODERNA

(1-866-663-3762)

ADDITIONAL INFORMATION

For general questions, visit the website or call the telephone number provided below.

To access the most recent Moderna COVID-19 Vaccine Fact Sheets, please scan the QR code or

visit the website provided below.


Website Telephone number

www.modernatx.com/covid19vaccine-eua

1-866-MODERNA

(1-866-663-3762)

AVAILABLE ALTERNATIVES

There is no approved alternative vaccine to prevent COVID-19. There may be clinical trials or

availability under EUA of other COVID-19 vaccines.

FEDERAL COVID-19 VACCINATION PROGRAM

This vaccine is being made available for emergency use exclusively through the CDC COVID-

19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as

providers in the Vaccination Program and comply with the provider requirements. Vaccination

providers may not charge any fee for the vaccine and may not charge the vaccine recipient any

out-of-pocket charge for administration. However, vaccination providers may seek appropriate

reimbursement from a program or plan that covers COVID-19 vaccine administration fees for

the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured

Program for non-insured recipients). For information regarding provider requirements and

enrollment in the CDC COVID-19 Vaccination Program, see

https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination

Program requirements are encouraged to report them to the Office of the Inspector General, U.S.

Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of the Department of Health and Human Services (HHS) has declared a public

health emergency that justifies the emergency use of drugs and biological products during the

COVID-19 Pandemic. In response, the FDA has issued an EUA for the unapproved product,

Moderna COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 18

years of age and older.

FDA issued this EUA, based on ModernaTX, Inc.’s request and submitted data.

Although limited scientific information is available, based on the totality of the scientific

evidence available to date, it is reasonable to believe that the Moderna COVID-19 Vaccine may

be effective for the prevention of COVID-19 in individuals as specified in the Full EUA

Prescribing Information.

This EUA for the Moderna COVID-19 Vaccine will end when the Secretary of HHS determines

that the circumstances justifying the EUA no longer exist or when there is a change in the


approval status of the product such that an EUA is no longer needed.

For additional information about Emergency Use Authorization, visit FDA at:

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-

framework/emergency-use-authorization.

COUNTERMEASURES INJURY COMPENSATION PROGRAM

The Countermeasures Injury Compensation Program (CICP) is a federal program that has been

created to help pay for related costs of medical care and other specific expenses to compensate

people injured after use of certain medical countermeasures. Medical countermeasures are

specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the

public during a public health emergency or a security threat. For more information about CICP

regarding the vaccines to prevent COVID-19, visit http://www.hrsa.gov/cicp, email

[email protected], or call: 1-855-266-2427.

Moderna US, Inc.

Cambridge, MA 02139

©2021 ModernaTX, Inc. All rights reserved.

Patent(s): www.modernatx.com/patents

Revised: Mar/31/2021

END SHORT VERSION FACT SHEET

Long Version (Full EUA Prescribing Information) Begins On Next Page


FULL EMERGENCY USE AUTHORIZATION (EUA)

PRESCRIBING INFORMATION

MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS*

1 AUTHORIZED USE

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration 2.2 Administration

2.3 Dosing and Schedule

3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

5.2 Altered Immunocompetence

5.3 Limitations of Vaccine Effectiveness

6 OVERALL SAFETY SUMMARY 6.1 Clinical Trials Experience

8 REQUIREMENTS AND INSTRUCTIONS FOR

REPORTING ADVERSE EVENTS AND VACCINE

ADMINISTRATION ERRORS

10 DRUG INTERACTIONS 11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

11.2 Lactation 11.3 Pediatric Use

11.4 Geriatric Use

13 DESCRIPTION 14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA

FOR EUA

19 HOW SUPPLIED/STORAGE AND HANDLING

20 PATIENT COUNSELING INFORMATION 21 CONTACT INFORMATION

*Sections or subsections omitted from the full prescribing

information are not listed

______________________________________________________________________________

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization

(EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age

and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

• The Moderna COVID-19 Vaccine multiple-dose vials contain a frozen suspension that

does not contain a preservative and must be thawed prior to administration.

• Remove the required number of vial(s) from storage and thaw each vial before use

following the instructions below.


Vial

Thaw in Refrigerator Thaw at Room Temperature

Maximum

11-Dose Vial

(range: 10-11

doses)


between 2° to 8°C for 2 hours

and 30 minutes. Let each vial

stand at room temperature for 15

minutes before administering.



25°C for 1 hour.

Maximum

15-Dose Vial

(range: 13-15

doses)


between 2° to 8°C for 3 hours.

Let each vial stand at room

temperature for 15 minutes

before administering.



25°C for 1 hour and 30

minutes.

• After thawing, do not refreeze.

• Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not

dilute the vaccine.

• The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain

white or translucent product-related particulates. Visually inspect the Moderna COVID-

19 Vaccine vials for other particulate matter and/or discoloration prior to administration.

If either of these conditions exists, the vaccine should not be administered.

• The Moderna COVID-19 Vaccine is supplied in two multiple-dose vial presentations:


mL each).


mL each).

• Depending on the syringes and needles used for each dose, there may not be sufficient

volume to extract more than 10 doses from the maximum of 11 doses vial or more than

13 doses from the maximum of 15 doses vial. Irrespective of the type of syringe and

needle:

o Each dose must contain 0.5 mL of vaccine.

o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5

mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.

o Pierce the stopper at a different site each time.

• After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36°

to 77°F). Record the date and time of first use on the Moderna COVID-19 Vaccine vial

label. Discard vial after 12 hours. Do not refreeze.

2.2 Administration

Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to

administration. The white to off-white suspension may contain white or translucent product-related

particulates. During the visual inspection,

• verify the final dosing volume of 0.5 mL.

• confirm there are no other particulates and that no discoloration is observed.

• do not administer if vaccine is discolored or contains other particulate matter.


Administer the Moderna COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule

The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5

mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with

other COVID-19 vaccines to complete the vaccination series. Individuals who have received one

dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19

Vaccine to complete the vaccination series.

3 DOSAGE FORMS AND STRENGTHS

Moderna COVID-19 Vaccine is a suspension for intramuscular injection. A single dose is 0.5

mL.

4 CONTRAINDICATIONS

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of

severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19

Vaccine [see Description (13)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately

available in the event an acute anaphylactic reaction occurs following administration of the

Moderna COVID-19 Vaccine.

Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse

reactions according to the Centers for Disease Control and Prevention guidelines

(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

5.2 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may

have a diminished response to the Moderna COVID-19 Vaccine.

5.3 Limitations of Vaccine Effectiveness

The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event

Reporting System (VAERS) all vaccine administration errors, all serious adverse events,

cases of Multi-inflammatory Syndrome (MIS) in adults, and hospitalized or fatal cases of


COVID-19 following vaccination with the Moderna COVID-19 Vaccine. To the extent

feasible, provide a copy of the VAERS form to ModernaTX, Inc. Please see the

REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND

VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and

ModernaTX, Inc.

In clinical studies, the adverse reactions in participants 18 years of age and older were pain at the

injection site (92.0%), fatigue (70.0%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%),

chills (45.4%), nausea/vomiting (23.0%), axillary swelling/tenderness (19.8%), fever (15.5%),

swelling at the injection site (14.7%), and erythema at the injection site (10.0%).

Severe allergic reactions, including anaphylaxis, have been reported following administration of

the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates

observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical

trials of another vaccine and may not reflect the rates observed in practice.

Overall, 15,419 participants aged 18 years and older received at least one dose of Moderna

COVID-19 Vaccine in three clinical trials (NCT04283461, NCT04405076, and NCT04470427).

The safety of Moderna COVID-19 Vaccine was evaluated in an ongoing Phase 3 randomized,

placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,351

participants 18 years of age and older who received at least one dose of Moderna COVID-19

Vaccine (n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the

mean age of the population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18

to 64 years of age and 7,520 (24.8%) of participants were 65 years of age and older. Overall,

52.7% were male, 47.3% were female, 20.5% were Hispanic or Latino, 79.2% were White,

10.2% were African American, 4.6% were Asian, 0.8% were American Indian or Alaska Native,

0.2% were Native Hawaiian or Pacific Islander, 2.1% were other races, and 2.1% were

Multiracial. Demographic characteristics were similar among participants who received Moderna

COVID-19 Vaccine and those who received placebo.

Solicited Adverse Reactions

Data on solicited local and systemic adverse reactions and use of antipyretic medication were

collected in an electronic diary for 7 days following each injection (i.e., day of vaccination and

the next 6 days) among participants receiving Moderna COVID-19 Vaccine (n=15,179) and

participants receiving placebo (n=15,163) with at least 1 documented dose. Solicited adverse

reactions were reported more frequently among vaccine participants than placebo participants.

The reported number and percentage of the solicited local and systemic adverse reactions by age

group and dose are presented in Table 1 and Table 2, respectively.


Table 1: Number and Percentage of Participants With Solicited Local and Systemic

Adverse Reactions Within 7 Days* After Each Dose in Participants 18-64 Years (Solicited

Safety Set, Dose 1 and Dose 2)

Moderna COVID-19 Vaccine

Placeboa

Dose 1

(N=11,406)

n (%)

Dose 2

(N=10,985)

n (%)

Dose 1

(N=11,407)

n (%)

Dose 2

(N=10,918)

n (%)

Local Adverse

Reactions

Pain 9,908

(86.9)

9,873

(89.9)

2,177

(19.1)

2,040

(18.7)

Pain, Grade 3b 366

(3.2)

506

(4.6)

23

(0.2)

22

(0.2)

Axillary

swelling/tenderness

1,322

(11.6)

1,775

(16.2)

567

(5.0)

470

(4.3)

Axillary

swelling/tenderness,

Grade 3b

37

(0.3)

46

(0.4)

13

(0.1)

11

(0.1)

Swelling (hardness)

≥25 mm

767

(6.7)

1,389

(12.6)

34

(0.3)

36

(0.3)

Swelling (hardness),

Grade 3c

62

(0.5)

182

(1.7)

3

(<0.1)

4

(<0.1)

Erythema (redness)

≥25 mm

344

(3.0)

982

(8.9)

47

(0.4)

43

(0.4)

Erythema (redness),

Grade 3c

34

(0.3)

210

(1.9)

11

(<0.1)

12

(0.1)

Systemic Adverse

Reactions

Fatigue 4,384

(38.4)

7,430

(67.6)

3,282

(28.8)

2,687

(24.6)

Fatigue, Grade 3d 120

(1.1)

1,174

(10.7)

83

(0.7)

86

(0.8)

Fatigue, Grade 4e 1

(<0.1)

0

(0)

0

(0)

0

(0)

Headache 4,030

(35.3)

6,898

(62.8)

3,304

(29.0)

2,760

(25.3)

Headache, Grade 3f 219

(1.9)

553

(5.0)

162

(1.4)

129

(1.2)

Myalgia 2,699

(23.7)

6,769

(61.6)

1,628

(14.3)

1,411

(12.9)

Myalgia, Grade 3d 73

(0.6)

1,113

(10.1)

38

(0.3)

42

(0.4)

Arthralgia 1,893

(16.6)

4,993

(45.5)

1,327

(11.6)

1,172

(10.7)

Arthralgia, Grade 3d 47

(0.4)

647

(5.9)

29

(0.3)

37

(0.3)

Arthralgia, Grade 4e 1

(<0.1)

0

(0)

0

(0)

0

(0)

Chills 1,051

(9.2)

5,341

(48.6)

730

(6.4)

658

(6.0)



Placeboa

Dose 1

(N=11,406)

n (%)

Dose 2

(N=10,985)

n (%)

Dose 1

(N=11,407)

n (%)

Dose 2

(N=10,918)

n (%)

Chills, Grade 3g 17

(0.1)

164

(1.5)

8

(<0.1)

15

(0.1)

Nausea/vomiting 1,068

(9.4)

2,348

(21.4)

908

(8.0)

801

(7.3)

Nausea/vomiting,

Grade 3h

6

(<0.1)

10

(<0.1)

8

(<0.1)

8

(<0.1)

Fever 105

(0.9)

1,908

(17.4)

37

(0.3)

39

(0.4)

Fever, Grade 3i 10

(<0.1)

184

(1.7)

1

(<0.1)

2

(<0.1)

Fever, Grade 4j 4

(<0.1)

12

(0.1)

4

(<0.1)

2

(<0.1)

Use of antipyretic or

pain medication

2,656

(23.3)

6,292

(57.3)

1,523

(13.4)

1,248

(11.4)

* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication

were collected in the electronic diary (e-diary). a Placebo was a saline solution. b Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily

activity. c Grade 3 swelling and erythema: Defined as >100 mm / >10 cm. d Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity. e Grade 4 fatigue, arthralgia: Defined as requires emergency room visit or hospitalization. f Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity. g Grade 3 chills: Defined as prevents daily activity and requires medical intervention. h Grade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration. i Grade 3 fever: Defined as ≥39.0° – ≤40.0°C / ≥102.1° – ≤104.0°F. j Grade 4 fever: Defined as >40.0°C / >104.0°F.

Table 2: Number and Percentage of Participants With Solicited Local and Systemic

Adverse Reactions Within 7 Days* After Each Dose in Participants 65 Years and Older

(Solicited Safety Set, Dose 1 and Dose 2)


Placeboa

Dose 1

(N=3,762)

n (%)

Dose 2

(N=3,692)

n (%)

Dose 1

(N=3,748)

n (%)

Dose 2

(N=3,648)

n (%)

Local Adverse

Reactions

Pain 2,782

(74.0)

3,070

(83.2)

481

(12.8)

437

(12.0)

Pain, Grade 3b 50

(1.3)

98

(2.7)

32

(0.9)

18

(0.5)

Axillary

swelling/tenderness

231

(6.1)

315

(8.5)

155

(4.1)

97

(2.7)

Axillary

swelling/tenderness,

Grade 3b

12

(0.3)

21

(0.6)

14

(0.4)

8

(0.2)



Placeboa

Dose 1

(N=3,762)

n (%)

Dose 2

(N=3,692)

n (%)

Dose 1

(N=3,748)

n (%)

Dose 2

(N=3,648)

n (%)

Swelling (hardness)

≥25 mm

165

(4.4)

400

(10.8)

18

(0.5)

13

(0.4)

Swelling (hardness),

Grade 3c

20

(0.5)

72

(2.0)

3

(<0.1)

7

(0.2)

Erythema (redness)

≥25 mm

86

(2.3)

275

(7.5)

20

(0.5)

13

(0.4)

Erythema (redness),

Grade 3c

8

(0.2)

77

(2.1)

2

(<0.1)

3

(<0.1)

Systemic Adverse

Reactions

Fatigue 1,251

(33.3)

2,152

(58.3)

851

(22.7)

716

(19.6)

Fatigue, Grade 3d 30

(0.8)

254

(6.9)

22

(0.6)

20

(0.5)

Headache 921

(24.5)

1,704

(46.2)

723

(19.3)

650

(17.8)

Headache, Grade 3e 52

(1.4)

106

(2.9)

34

(0.9)

33

(0.9)

Myalgia 742

(19.7)

1,739

(47.1)

443

(11.8)

398

(10.9)

Myalgia, Grade 3d 17

(0.5)

205

(5.6)

9

(0.2)

10

(0.3)

Arthralgia 618

(16.4)

1,291

(35.0)

456

(12.2)

397

(10.9)

Arthralgia, Grade 3d 13

(0.3)

123

(3.3)

8

(0.2)

7

(0.2)

Chills 202

(5.4)

1,141

(30.9)

148

(4.0)

151

(4.1)

Chills, Grade 3f 7

(0.2)

27

(0.7)

6

(0.2)

2

(<0.1)

Nausea/vomiting 194

(5.2)

437

(11.8)

166

(4.4)

133

(3.6)

Nausea/vomiting,

Grade 3g

4

(0.1)

10

(0.3)

4

(0.1)

3

(<0.1)

Nausea/vomiting,

Grade 4h

0

(0)

1

(<0.1)

0

(0)

0

(0)

Fever 10

(0.3)

370

(10.0)

7

(0.2)

4

(0.1)

Fever, Grade 3i 1

(<0.1)

18

(0.5)

1

(<0.1)

0

(0)

Fever, Grade 4j 0

(0)

1

(<0.1)

2

(<0.1)

1

(<0.1)

Use of antipyretic or

pain medication

673

(17.9)

1,546

(41.9)

477

(12.7)

329

(9.0)

* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication

were collected in the electronic diary (e-diary). a Placebo was a saline solution.


b Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily

activity. c Grade 3 swelling and erythema: Defined as >100 mm / >10 cm. d Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity. e Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity. f Grade 3 chills: Defined as prevents daily activity and requires medical intervention. g Grade 3 Nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration. h Grade 4 Nausea/vomiting: Defined as requires emergency room visit or hospitalization for hypotensive shock. i Grade 3 fever: Defined as ≥39.0° – ≤40.0°C / ≥102.1° – ≤104.0°F. j Grade 4 fever: Defined as >40.0°C / >104.0°F.

Solicited local and systemic adverse reactions reported following administration of Moderna

COVID-19 Vaccine had a median duration of 1 to 3 days.

Grade 3 solicited local adverse reactions were more frequently reported after Dose 2 than after

Dose 1. Solicited systemic adverse reactions were more frequently reported by vaccine recipients

after Dose 2 than after Dose 1.

Unsolicited Adverse Events

Participants were monitored for unsolicited adverse events for up to 28 days following each dose

and follow-up is ongoing. Serious adverse events and medically attended adverse events will be

recorded for the entire study duration of 2 years. As of November 25, 2020, among participants

who had received at least 1 dose of vaccine or placebo (vaccine=15,185, placebo=15,166),

unsolicited adverse events that occurred within 28 days following each vaccination were reported

by 23.9% of participants (n=3,632) who received Moderna COVID-19 Vaccine and 21.6% of

participants (n=3,277) who received placebo. In these analyses, 87.9% of study participants had

at least 28 days of follow-up after Dose 2.

Lymphadenopathy-related events that were not necessarily captured in the 7-day e-diary were

reported by 1.1% of vaccine recipients and 0.6% of placebo recipients. These events included

lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy,

injection-site lymphadenopathy, and axillary mass, which were plausibly related to vaccination.

This imbalance is consistent with the imbalance observed for solicited axillary

swelling/tenderness in the injected arm.

Hypersensitivity adverse events were reported in 1.5% of vaccine recipients and 1.1% of placebo

recipients. Hypersensitivity events in the vaccine group included injection site rash and injection

site urticaria, which are likely related to vaccination. Delayed injection site reactions that began

>7 days after vaccination were reported in 1.2% of vaccine recipients and 0.4% of placebo

recipients. Delayed injection site reactions included pain, erythema, and swelling and are likely

related to vaccination.

Throughout the same period, there were three reports of Bell’s palsy in the Moderna COVID-19

Vaccine group (one of which was a serious adverse event), which occurred 22, 28, and 32 days

after vaccination, and one in the placebo group which occurred 17 days after vaccination.

Currently available information on Bell’s palsy is insufficient to determine a causal relationship

with the vaccine.


There were no other notable patterns or numerical imbalances between treatment groups for

specific categories of adverse events (including other neurologic, neuro-inflammatory, and

thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Serious Adverse Events

As of November 25, 2020, serious adverse events were reported by 1.0% (n=147) of participants

who received Moderna COVID-19 Vaccine and 1.0% (n=153) of participants who received

placebo, one of which was the case of Bell’s palsy which occurred 32 days following receipt of

vaccine.

In these analyses, 87.9% of study participants had at least 28 days of follow-up after Dose 2, and

the median follow-up time for all participants was 9 weeks after Dose 2.

There were two serious adverse events of facial swelling in vaccine recipients with a history of

injection of dermatological fillers. The onset of swelling was reported 1 and 2 days, respectively,

after vaccination and was likely related to vaccination.

There was one serious adverse event of intractable nausea and vomiting in a participant with

prior history of severe headache and nausea requiring hospitalization. This event occurred 1 day

after vaccination and was likely related to vaccination.

There were no other notable patterns or imbalances between treatment groups for specific

categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic

events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS

AND VACCINE ADMINISTRATION ERRORS

See Overall Safety Summary (Section 6) for additional information.

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible

for the MANDATORY reporting of the listed events following Moderna COVID-19 Vaccine to

the Vaccine Adverse Event Reporting System (VAERS)

• Vaccine administration errors whether or not associated with an adverse event

• Serious adverse events* (irrespective of attribution to vaccination)

• Cases of multisystem inflammatory syndrome (MIS) in adults

• Cases of COVID-19 that results in hospitalization or death

*Serious Adverse Events are defined as:

• Death;

• A life-threatening adverse event;

• Inpatient hospitalization or prolongation of existing hospitalization;

• A persistent or significant incapacity or substantial disruption of the ability to conduct


normal life functions;

• A congenital anomaly/birth defect;

• An important medical event that based on appropriate medical judgement may jeopardize

the individual and may require medical or surgical intervention to prevent one of the

outcomes listed above.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should

complete and submit a VAERS form to FDA using one of the following methods:

• Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or

• If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-

721-0366. If you need additional help submitting a report, you may call the VAERS toll-

free information line at 1-800-822-7967 or send an email to [email protected].

IMPORTANT: When reporting adverse events or vaccine administration errors to

VAERS, please complete the entire form with detailed information. It is important that the

information reported to FDA be as detailed and complete as possible. Information to

include:

• Patient demographics (e.g., patient name, date of birth)

• Pertinent medical history

• Pertinent details regarding admission and course of illness

• Concomitant medications

• Timing of adverse event(s) in relationship to administration of Moderna COVID-19

Vaccine

• Pertinent laboratory and virology information

• Outcome of the event and any additional follow-up information if it is available at the

time of the VAERS report. Subsequent reporting of follow-up information should be

completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

1. In Box 17, provide information on Moderna COVID-19 Vaccine and any other vaccines

administered on the same day; and in Box 22, provide information on any other vaccines

received within one month prior.

2. In Box 18, description of the event:

a. Write “Moderna COVID-19 Vaccine EUA” as the first line

b. Provide a detailed report of vaccine administration error and/or adverse event. It

is important to provide detailed information regarding the patient and adverse

event/medication error for ongoing safety evaluation of this unapproved vaccine.

Please see information to include listed above.

3. Contact information:

a. In Box 13, provide the name and contact information of the prescribing healthcare

provider or institutional designee who is responsible for the report.

b. In Box 14, provide the name and contact information of the best doctor/healthcare

professional to contact about the adverse event.


c. In Box 15, provide the address of the facility where vaccine was given (NOT the

healthcare provider’s office address).

Other Reporting Instructions

Vaccination providers may report to VAERS other adverse events that are not required to be

reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information

below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email

Fax number Telephone number

[email protected] 1-866-599-1342 1-866-MODERNA

(1-866-663-3762)

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Moderna COVID-19 Vaccine

with other vaccines.

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to

Moderna COVID-19 Vaccine during pregnancy. Women who are vaccinated with Moderna

COVID-19 Vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866-

MODERNA (1-866-663-3762).

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general

population, the estimated background risk of major birth defects and miscarriage in clinically

recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Moderna

COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-

associated risks in pregnancy.

In a developmental toxicity study, 0.2 mL of a vaccine formulation containing the same quantity

of nucleoside-modified messenger ribonucleic acid (mRNA) (100 mcg) and other ingredients

included in a single human dose of Moderna COVID-19 Vaccine was administered to female rats

by the intramuscular route on four occasions: 28 and 14 days prior to mating, and on gestation

days 1 and 13. No vaccine-related adverse effects on female fertility, fetal development, or

postnatal development were reported in the study.


11.2 Lactation

Risk Summary

Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed

infant or on milk production/excretion.

11.3 Pediatric Use

Safety and effectiveness have not been assessed in persons less than 18 years of age. Emergency

Use Authorization of Moderna COVID-19 Vaccine does not include use in individuals younger

than 18 years of age.

11.4 Geriatric Use

Clinical studies of Moderna COVID-19 Vaccine included participants 65 years of age and older

receiving vaccine or placebo, and their data contribute to the overall assessment of safety and

efficacy. In an ongoing Phase 3 clinical study, 24.8% (n=7,520) of participants were 65 years of

age and older and 4.6% (n=1,399) of participants were 75 years of age and older. Vaccine

efficacy in participants 65 years of age and older was 86.4% (95% CI 61.4, 95.2) compared to

95.6% (95% CI 90.6, 97.9) in participants 18 to <65 years of age [see Clinical Trial Results and

Supporting Data for EUA (18)]. Overall, there were no notable differences in the safety profiles

observed in participants 65 years of age and older and younger participants [see Overall Safety

Summary (6.1)].

13 DESCRIPTION

Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular

injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-

modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of

SARS-CoV-2 virus.

Each dose of the Moderna COVID-19 Vaccine contains the following ingredients: a total lipid

content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG],

cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.31 mg tromethamine,

1.18 mg tromethamine hydrochloride, 0.043 mg acetic acid, 0.20 mg sodium acetate trihydrate,

and 43.5 mg sucrose.

Moderna COVID-19 Vaccine does not contain a preservative.

The vial stoppers are not made with natural rubber latex.


14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

The nucleoside-modified mRNA in the Moderna COVID-19 Vaccine is formulated in lipid

particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow

expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S

antigen, which protects against COVID-19.

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

A Phase 3 randomized, placebo-controlled, observer-blind clinical trial to evaluate the efficacy,

safety, and immunogenicity of the Moderna COVID-19 Vaccine in participants 18 years of age

and older is ongoing in the United States (NCT04470427). Randomization was stratified by age

and health risk: 18 to <65 years of age without comorbidities (not at risk for progression to

severe COVID-19), 18 to <65 years of age with comorbidities (at risk for progression to severe

COVID-19), and 65 years of age and older with or without comorbidities. Participants who were

immunocompromised and those with a known history of SARS-CoV-2 infection were excluded

from the study. Participants with no known history of SARS-CoV-2 infection but with positive

laboratory results indicative of infection at study entry were included. The study allowed for the

inclusion of participants with stable pre-existing medical conditions, defined as disease not

requiring significant change in therapy or hospitalization for worsening disease during the 3

months before enrollment, as well as participants with stable human immunodeficiency virus

(HIV) infection. A total of 30,420 participants were randomized equally to receive 2 doses of the

Moderna COVID-19 Vaccine or saline placebo 1 month apart. Participants will be followed for

efficacy and safety until 24 months after the second dose.

The primary efficacy analysis population (referred to as the Per-Protocol Set) included 28,207

participants who received two doses (at 0 and 1 month) of either Moderna COVID-19 Vaccine

(n=14,134) or placebo (n=14,073), and had a negative baseline SARS-CoV-2 status. In the Per-

Protocol Set, 47.4% were female, 19.7% were Hispanic or Latino; 79.5% were White, 9.7% were

African American, 4.6% were Asian, and 2.1% other races. The median age of participants was

53 years (range 18-95) and 25.3% of participants were 65 years of age and older. Of the study

participants in the Per-Protocol Set, 18.5% were at increased risk of severe COVID-19 due to at

least one pre-existing medical condition (chronic lung disease, significant cardiac disease, severe

obesity, diabetes, liver disease, or HIV infection) regardless of age. Between participants who

received Moderna COVID-19 Vaccine and those who received placebo, there were no notable

differences in demographics or pre-existing medical conditions.

Efficacy Against COVID-19

COVID-19 was defined based on the following criteria: The participant must have experienced

at least two of the following systemic symptoms: fever (≥38ºC), chills, myalgia, headache, sore

throat, new olfactory and taste disorder(s); or the participant must have experienced at least one

of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing,

or clinical or radiographical evidence of pneumonia; and the participant must have at least one


NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-

CoV-2 by RT-PCR. COVID-19 cases were adjudicated by a Clinical Adjudication Committee.

The median length of follow up for efficacy for participants in the study was 9 weeks post Dose

2. There were 11 COVID-19 cases in the Moderna COVID-19 Vaccine group and 185 cases in

the placebo group, with a vaccine efficacy of 94.1% (95% confidence interval of 89.3% to

96.8%).

Table 3: Primary Efficacy Analysis: COVID-19* in Participants 18 Years of Age and Older

Starting 14 Days After Dose 2 per Adjudication Committee Assessments – Per-Protocol Set

Moderna COVID-19 Vaccine Placebo

% Vaccine

Efficacy

(95% CI)†

Participants

(N)

COVID-19

Cases

(n)

Incidence

Rate of

COVID-19

per 1,000

Person-

Years

Participants

(N)

COVID-19

Cases

(n)

Incidence

Rate of

COVID-19

per 1,000

Person-

Years

14,134 11 3.328 14,073 185 56.510 94.1

(89.3, 96.8)

* COVID-19: symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one

respiratory symptom. Cases starting 14 days after Dose 2. 

† VE and 95% CI from the stratified Cox proportional hazard model. 

The subgroup analyses of vaccine efficacy are presented in Table 4.

Table 4: Subgroup Analyses of Vaccine Efficacy: COVID-19* Cases Starting 14 Days After

Dose 2 per Adjudication Committee Assessments – Per- Protocol Set

Age

Subgroup

(Years)

Moderna COVID-19 Vaccine Placebo

%

Vaccine

Efficacy

(95%

CI)*

Participants

(N)

COVID-19

Cases

(n)

Incidence

Rate of

COVID-19

per 1,000

Person-

Years

Participants

(N)

COVID-19

Cases

(n)

Incidence

Rate of

COVID-19

per 1,000

Person-

Years

18 to <65 10,551 7 2.875 10,521 156 64.625 95.6

(90.6, 97.9)

≥65 3,583 4 4.595 3,552 29 33.728 86.4

(61.4, 95.2)

* COVID-19: symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one

respiratory symptom. Cases starting 14 days after Dose 2.

† VE and 95% CI from the stratified Cox proportional hazard model.

Severe COVID-19 was defined based on confirmed COVID-19 as per the primary efficacy

endpoint case definition, plus any of the following: Clinical signs indicative of severe systemic

illness, respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room


air at sea level or PaO2/FIO2 <300 mm Hg; or respiratory failure or ARDS (defined as needing

high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock

(systolic blood pressure <90 mmHg, diastolic BP <60 mmHg or requiring vasopressors); or

significant acute renal, hepatic, or neurologic dysfunction; or admission to an intensive care unit

or death.

Among all participants in the Per-Protocol Set analysis, which included COVID-19 cases

confirmed by an adjudication committee, no cases of severe COVID-19 were reported in the

Moderna COVID-19 Vaccine group compared with 30 cases reported in the placebo group

(incidence rate 9.138 per 1,000 person-years). One PCR-positive case of severe COVID-19 in a

vaccine recipient was awaiting adjudication at the time of the analysis.

19 HOW SUPPLIED/STORAGE AND HANDLING

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection Multiple-Dose Vials are

supplied as follows:

NDC 80777-273-99 Carton of 10 multiple-dose vials, each vial containing a maximum of

11 doses: range 10-11 doses (0.5 mL)

NDC 80777-273-98 Carton of 10 multiple-dose vials, each vial containing a maximum of

15 doses: range 13-15 doses (0.5 mL)

During storage, minimize exposure to room light.

Store frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.

Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures

colder than -50°C (-58°F).

Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first

use. Do not refreeze.

Vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to

77°F). Vials should be discarded 12 hours after the first puncture.

Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

Transportation of Thawed Vials at 2°C to 8°C (35°F to 46°F)

If transport at -50° to -15°C (-58° to 5°F) is not feasible, available data support transportation of

one or more thawed vials for up to 12 hours at 2° to 8°C (35° to 46°F) when shipped using


shipping containers which have been qualified to maintain 2° to 8°C (35° to 46°F) and under

routine road and air transport conditions with shaking and vibration minimized. Once thawed and

transported at 2° to 8°C (35° to 46°F), vials should not be refrozen and should be stored at 2° to

8°C (35° to 46°F) until use.

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.

The vaccination provider must include vaccination information in the state/local jurisdiction’s

Immunization Information System (IIS) or other designated system. Advise recipient or caregiver

that more information about IISs can be found at:

https://www.cdc.gov/vaccines/programs/iis/about.html.

21 CONTACT INFORMATION

For general questions, send an email or call the telephone number provided below.

Email Telephone number

[email protected] 1-866-MODERNA

(1-866-663-3762)

This EUA Prescribing Information may have been updated. For the most resent Full EUA

Prescribing Information, please visit www.modernatx.com/covid19vaccine-eua.

Moderna US, Inc.

Cambridge, MA 02139




about:blank


FACT SHEET FOR RECIPIENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF

THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019

(COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER

You are being offered the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019

(COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you

understand the risks and benefits of the Moderna COVID-19 Vaccine, which you may receive

because there is currently a pandemic of COVID-19.

The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19.

There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.

Read this Fact Sheet for information about the Moderna COVID-19 Vaccine. Talk to the

vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19

Vaccine.

The Moderna COVID-19 Vaccine is administered as a 2-dose series, 1 month apart, into the

muscle.

The Moderna COVID-19 Vaccine may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit

www.modernatx.com/covid19vaccine-eua.

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

WHAT IS COVID-19?

COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not

been seen before. You can get COVID-19 through contact with another person who has the

virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-

19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness.

Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or

chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or

smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE MODERNA COVID-19 VACCINE?

The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There

is no FDA-approved vaccine to prevent COVID-19.

The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent

COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization

(EUA).

For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?”

section at the end of this Fact Sheet.


WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE

YOU GET THE MODERNA COVID-19 VACCINE?

Tell your vaccination provider about all of your medical conditions, including if you:

• have any allergies

• have a fever

• have a bleeding disorder or are on a blood thinner

• are immunocompromised or are on a medicine that affects your immune system

• are pregnant or plan to become pregnant

• are breastfeeding

• have received another COVID-19 vaccine

WHO SHOULD GET THE MODERNA COVID-19 VACCINE?

FDA has authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18

years of age and older.

WHO SHOULD NOT GET THE MODERNA COVID-19 VACCINE?

You should not get the Moderna COVID-19 Vaccine if you:

• had a severe allergic reaction after a previous dose of this vaccine

• had a severe allergic reaction to any ingredient of this vaccine

WHAT ARE THE INGREDIENTS IN THE MODERNA COVID-19 VACCINE?

The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid

(mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG],

cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine,

tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose.

HOW IS THE MODERNA COVID-19 VACCINE GIVEN?

The Moderna COVID-19 Vaccine will be given to you as an injection into the muscle.

The Moderna COVID-19 Vaccine vaccination series is 2 doses given 1 month apart.

If you receive one dose of the Moderna COVID-19 Vaccine, you should receive a second dose of

the same vaccine 1 month later to complete the vaccination series.

HAS THE MODERNA COVID-19 VACCINE BEEN USED BEFORE?

The Moderna COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately

15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna

COVID-19 Vaccine.

WHAT ARE THE BENEFITS OF THE MODERNA COVID-19 VACCINE?

In an ongoing clinical trial, the Moderna COVID-19 Vaccine has been shown to prevent

COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19

is currently unknown.


WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE?

There is a remote chance that the Moderna COVID-19 Vaccine could cause a severe allergic

reaction. A severe allergic reaction would usually occur within a few minutes to one hour after

getting a dose of the Moderna COVID-19 Vaccine. For this reason, your vaccination provider

may ask you to stay at the place where you received your vaccine for monitoring after

vaccination. Signs of a severe allergic reaction can include:

• Difficulty breathing

• Swelling of your face and throat

• A fast heartbeat

• A bad rash all over your body

• Dizziness and weakness

Side effects that have been reported in a clinical trial with the Moderna COVID-19 Vaccine

include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm

of the injection, swelling (hardness), and redness

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and

vomiting, and fever

Side effects that have been reported during post-authorization use of the Moderna COVID-19

Vaccine include:

• Severe allergic reactions

These may not be all the possible side effects of the Moderna COVID-19 Vaccine. Serious and

unexpected side effects may occur. The Moderna COVID-19 Vaccine is still being studied in

clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother

you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System

(VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to

https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine EUA” in

the first line of box #18 of the report form.

In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-

3762).

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based

tool that uses text messaging and web surveys to check in with people who have been vaccinated

to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help

CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if


needed and live telephone follow-up by CDC if participants report a significant health impact

following COVID-19 vaccination. For more information on how to sign up, visit:

www.cdc.gov/vsafe.

WHAT IF I DECIDE NOT TO GET THE MODERNA COVID-19 VACCINE?

It is your choice to receive or not receive the Moderna COVID-19 Vaccine. Should you decide

not to receive it, it will not change your standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES

MODERNA COVID-19 VACCINE?

Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19.

Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

CAN I RECEIVE THE MODERNA COVID-19 VACCINE WITH OTHER VACCINES?

There is no information on the use of the Moderna COVID-19 Vaccine with other vaccines.

WHAT IF I AM PREGNANT OR BREASTFEEDING?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

WILL THE MODERNA COVID-19 VACCINE GIVE ME COVID-19?

No. The Moderna COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you

COVID-19.

KEEP YOUR VACCINATION CARD

When you receive your first dose, you will get a vaccination card to show you when to return for

your second dose of the Moderna COVID-19 Vaccine. Remember to bring your card when you

return.

ADDITIONAL INFORMATION

If you have questions, visit the website or call the telephone number provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

Moderna COVID-19 Vaccine website Telephone number

www.modernatx.com/covid19vaccine-eua

1-866-MODERNA

(1-866-663-3762)


HOW CAN I LEARN MORE?

• Ask the vaccination provider

• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html

• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-

regulatory-and-policy-framework/emergency-use-authorization

• Contact your state or local public health department

WHERE WILL MY VACCINATION INFORMATION BE RECORDED?

The vaccination provider may include your vaccination information in your state/local

jurisdiction’s Immunization Information System (IIS) or other designated system. This will

ensure that you receive the same vaccine when you return for the second dose. For more

information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19

VACCINE?

No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged

an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19

vaccination. However, vaccination providers may seek appropriate reimbursement from a

program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient

(private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured

recipients).

WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination

Program requirements are encouraged to report them to the Office of the Inspector General, U.S.

Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.

WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help

pay for costs of medical care and other specific expenses of certain people who have been

seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim

must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To

learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

The United States FDA has made the Moderna COVID-19 Vaccine available under an

emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health

and Human Services (HHS) declaration that circumstances exist to justify the emergency use of

drugs and biological products during the COVID-19 pandemic.

The Moderna COVID-19 Vaccine has not undergone the same type of review as an FDA-

approved or cleared product. FDA may issue an EUA when certain criteria are met, which

includes that there are no adequate, approved, and available alternatives. In addition, the FDA

decision is based on the totality of the scientific evidence available showing that the product may

be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and

potential benefits of the product outweigh the known and potential risks of the product. All of


these criteria must be met to allow for the product to be used during the COVID-19 pandemic.

The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19

EUA declaration justifying emergency use of these products, unless terminated or revoked (after

which the products may no longer be used).

Moderna US, Inc.

Cambridge, MA 02139




Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems.

Barcode Date: 04/2021

February 25, 2021

ModernaTX, Inc. Attention: Ms. Carlota Vinals 200 Technology Square Cambridge, MA 02139 Dear Ms. Vinals: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2 On December 18, 2020, FDA issued an Emergency Use Authorization (EUA) for emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 for individuals 18 years of age and older, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Act. On February 25, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the December 18, 2020, letter in its entirety with revisions incorporated to allow flexibility on the date of submission of monthly periodic safety reports and to revise the requirements for reporting of vaccine administration errors by ModernaTX, Inc. Moderna COVID‑19 Vaccine is for use for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. The vaccine contains a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. It is an investigational vaccine not licensed for any indication. 1 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020.

2 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020).

ModernaTX, Inc.

FDA reviewed safety and efficacy data from an ongoing phase 3 trial in approximately 30,000 participants randomized 1:1 to receive Moderna COVID‑19 Vaccine or saline control. The trial has enrolled participants 18 years of age and older. FDA’s review of the available safety data from 30,351 participants 18 years of age and older, who were followed for a median of 7 weeks after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA. Review of additional safety data from these participants with a median of 9 weeks of follow-up after receipt of the second dose did not change FDA’s assessment of safety of the vaccine. FDA’s analysis of the efficacy data from 28,207 participants 18 years of age and older without evidence of SARS-CoV-2 infection prior to dose 1 confirms the vaccine was 94.1% effective (95% confidence interval (CI) 89.3, 96.8) in preventing COVID-19 occurring at least 14 days after the second dose (with 11 COVID-19 cases in the vaccine group compared to 185 COVID-19 cases in the placebo group). In this final scheduled analysis participants had been followed for a median of 9 weeks following the second dose. This result is consistent with that obtained from an interim analysis of efficacy conducted after these participants had been followed for a median of 7 weeks after the second dose (vaccine efficacy 94.5%, 95% CI: 86.5, 97.8). Based on the safety and effectiveness data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Moderna COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 18 years of age and older. Finally, on December 17, 2020, the Vaccines and Related Biological Products Advisory Committee voted in agreement with this conclusion. Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Moderna COVID-19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. I. Criteria for Issuance of Authorization I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Moderna COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and

ModernaTX, Inc.

3. There is no adequate, approved, and available alternative to the emergency use of

Moderna COVID-19 Vaccine to prevent COVID-19.3

II. Scope of Authorization I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:

• ModernaTX, Inc. will supply Moderna COVID‑19 Vaccine either directly or through authorized distributor(s)4 to emergency response stakeholders5 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA;

• The Moderna COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers6 and used only to prevent COVID-19 in individuals ages 18 and older; and

• The Moderna COVID‑19 Vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient.

3 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.

4 “Authorized Distributor(s)” are identified by ModernaTX, Inc. or, if applicable, by a U.S. government entity, such as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to distribute authorized Moderna COVID‑19 Vaccine.

5 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination providers will all be met.

6 For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health officer) to administer or provide vaccination services in accordance with the applicable emergency response stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC COVID-19 Vaccination Program. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S. Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).

ModernaTX, Inc.

Product Description The Moderna COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials.. The Moderna COVID-19 Vaccine does not contain a preservative. Each 0.5 mL dose of the Moderna COVID-19 Vaccine contains 100 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Moderna COVID-19 Vaccine also includes the following ingredients: lipids (SM-102; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG]; cholesterol; and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose. The dosing regimen is two doses of 0.5 mL each, one month apart. The manufacture of the authorized Moderna COVID‑19 Vaccine is limited to those facilities identified and agreed upon in the ModernaTX, Inc. request for authorization. The Moderna COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Moderna COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act. The Moderna COVID‑19 Vaccine is authorized for emergency use with the following product-specific information required to be made available to vaccination providers and recipients, respectively (referred to as “authorized labeling”):

• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Moderna COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)

• Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the Moderna COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older

I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of Moderna COVID‑19 Vaccine, when used to prevent COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its known and potential risks. I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.

ModernaTX, Inc.

Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, I have concluded that Moderna COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of Moderna COVID‑19 Vaccine under this EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), Moderna COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals 18 years of age and older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law. III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: ModernaTX, Inc. and Authorized Distributor(s)

A. ModernaTX, Inc. and authorized distributor(s) will ensure that the authorized Moderna COVID‑19 Vaccine is distributed, as directed by the U.S. government, including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets) will be made available to vaccination providers, recipients, and caregivers consistent with the terms of this letter.

B. ModernaTX, Inc. and authorized distributor(s) will ensure that appropriate storage

and cold chain is maintained until delivered to emergency response stakeholders’ receipt sites.

C. ModernaTX, Inc. will ensure that the terms of this EUA are made available to all

relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Moderna COVID‑19 Vaccine. ModernaTX, Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling.

D. ModernaTX, Inc. may develop and disseminate instructional and educational

materials (e.g., video regarding vaccine handling, storage/cold-chain management, preparation, disposal) that are consistent with the authorized emergency use of the vaccine as described in the letter of authorization and authorized labeling, without FDA’s review and concurrence, when necessary to meet public health needs during an emergency. Any instructional and educational materials that are inconsistent with the authorized labeling are prohibited.

ModernaTX, Inc.

E. ModernaTX, Inc. may request changes to this authorization, including to the authorized Fact Sheets for Moderna COVID‑19 Vaccine. Any request for changes to this EUA must be submitted to Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation and Research (CBER). Such changes require appropriate authorization prior to implementation7.

F. ModernaTX, Inc. will report to Vaccine Adverse Event Reporting System (VAERS):

• Serious adverse events (irrespective of attribution to vaccination); • Cases of Multisystem Inflammatory Syndrome in adults; and • Cases of COVID-19 that result in hospitalization or death, that are reported to

ModernaTX, Inc. These reports should be submitted to VAERS as soon as possible but no later than 15 calendar days from initial receipt of the information by ModernaTX, Inc.

G. ModernaTX, Inc. must submit to Investigational New Drug application (IND)

number 19745 periodic safety reports at monthly intervals, in accordance with a due date agreed upon with the Office of Biostatistics and Epidemiology (OBE), beginning after the first full calendar month after authorization. Each periodic safety report is required to contain descriptive information which includes: • A narrative summary and analysis of adverse events submitted during the

reporting interval, including interval and cumulative counts by age groups, special populations (e.g., pregnant women), and adverse events of special interest;

• A narrative summary and analysis of vaccine administration errors, whether or not associated with an adverse event, that were identified since the last reporting interval;

• Newly identified safety concerns in the interval; and • Actions taken since the last report because of adverse experiences (for example,

changes made to Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet, changes made to studies or studies initiated).

H. No changes will be implemented to the description of the product, manufacturing

process, facilities, or equipment without notification to and concurrence by the Agency.

I. All manufacturing facilities will comply with Current Good Manufacturing Practice

requirements.

7 The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to require data collection or study. For changes to the authorization, including the authorized labeling, of the type listed in (3), (6), or (7), review and concurrence is required from the Preparedness and Response Team (PREP)/Office of the Center Director (OD)/CBER and the Office of Counterterrorism and Emerging Threats (OCET)/Office of the Chief Scientist (OCS).

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J. ModernaTX, Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug product lot at least 48 hours prior to vaccine distribution. The CoA will include the established specifications and specific results for each quality control test performed on the final drug product lot.

K. ModernaTX, Inc. will submit to the EUA file quarterly manufacturing reports that

include a listing of all Drug Substance and Drug Product lots produced after issuance of this authorization. This report must include lot number, manufacturing site, date of manufacture, and lot disposition, including those lots that were quarantined for investigation or those lots that were rejected. Information on the reasons for lot quarantine or rejection must be included in the report. The first report is due July 2021.

L. ModernaTX, Inc. and authorized distributor(s) will maintain records regarding release

of Moderna COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity, release date).

M. ModernaTX, Inc. and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA.

N. ModernaTX, Inc. will conduct post-authorization observational studies to evaluate the association between Moderna COVID-19 Vaccine and a pre-specified list of adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19. The study population should include individuals administered the authorized Moderna COVID-19 Vaccine under this EUA in the general U.S. population (18 years of age and older), populations of interest such as healthcare workers, pregnant women, immunocompromised individuals, subpopulations with specific comorbidities. The studies should be conducted in large scale databases with an active comparator. ModernaTX, Inc. will provide protocols and status update reports to the IND 19745 with agreed-upon study designs and milestone dates.

O. ModernaTX, Inc., working with its contract research organization, will continue to monitor the performance of its clinical investigators in ongoing clinical studies of its vaccine and will report to FDA promptly any significant deviations from the protocols.

Emergency Response Stakeholders

P. Emergency response stakeholders will identify vaccination sites to receive authorized Moderna COVID‑19 Vaccine and ensure its distribution and administration, consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.

Q. Emergency response stakeholders will ensure that vaccination providers within their jurisdictions are aware of this letter of authorization, and the terms herein and any subsequent amendments that might be made to the letter of authorization, instruct them about the means through which they are to obtain and administer the vaccine

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under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers] is made available to vaccination providers through appropriate means (e.g., e-mail, website).

R. Emergency response stakeholders receiving authorized Moderna COVID‑19 Vaccine will ensure that appropriate storage and cold chain is maintained.

Vaccination Providers

S. Vaccination providers will administer the vaccine in accordance with the authorization and will participate and comply with the terms and training required by CDC’s COVID-19 Vaccination Program.

T. Vaccination providers will provide the Fact Sheet for Recipients and Caregivers to

each individual receiving vaccination and provide the necessary information for receiving their second dose.

U. Vaccination providers administering Moderna COVID‑19 Vaccine must report the

following information associated with the administration of Moderna COVID‑19 Vaccine of which they become aware to VAERS in accordance with the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): • Vaccine administration errors whether or not associated with an adverse event • Serious adverse events (irrespective of attribution to vaccination) • Cases of Multisystem Inflammatory Syndrome in adults • Cases of COVID-19 that result in hospitalization or death

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the words “ Moderna COVID‑19 Vaccine EUA” in the description section of the report. More information is available at vaers.hhs.gov or by calling 1-800-822-7967. To the extent feasible, report to ModernaTX, Inc., by contacting 1-866-663-3762, by providing a copy of the VAERS form to ModernaTX, Inc., Fax: 1-866-599-1342 or by email; [email protected].

V. Vaccination providers will conduct any follow-up requested by the U.S government, including CDC, FDA, or other designee, regarding adverse events to the extent feasible given the emergency circumstances.

W. Vaccination providers will monitor and comply with CDC and/or emergency

response stakeholder vaccine management requirements (e.g., requirements concerning obtaining, tracking, and handling vaccine) and with requirements concerning reporting of vaccine administration data to CDC.

X. Vaccination providers will ensure that any records associated with this EUA are

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maintained until notified by FDA. Such records will be made available to CDC and FDA for inspection upon request.

Conditions Related to Printed Matter, Advertising, and Promotion

Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Moderna COVID‑19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.

Z. All descriptive printed matter, advertising, and promotional material relating to the

use of the Moderna COVID‑19 Vaccine clearly and conspicuously shall state that: • This product has not been approved or licensed by FDA, but has been

authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 18 years of age and older; and

• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

IV. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

Sincerely,

____________________________ RADM Denise M. Hinton Chief Scientist Food and Drug Administration

Enclosures

thaw each vial before use - moderna, inc. | home...2 to 8 c (36 to 46 f) 8 to 25 c (46 to 77 f)...

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